Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))

Conditions

• Subjects With Hyperlipidemia, Dyslipidemia

Eligibility Criteria

Sex

ALL

Age

50 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — DRUG
  Administered subcutaneously once a month using an autoinjector/pen.
• Placebo — DRUG
  Administered subcutaneously once a month using an autoinjector/pen.

Study Details

A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).

Key Dates

Start date

Apr 14, 2016

Status verified

Sep 2022

Primary completion

Apr 5, 2018

Completion

Apr 5, 2018

Study Design

Enrollment

129 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received placebo to evolocumab by subcutaneous injection once a month (QM) for 12 weeks.
• Experimental: Evolocumab 420 mg QM
  Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 [ Time Frame: Baseline and week 16 ]

Locations (5)

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